Certificate of RegistrationQUALITY MANAGEMENT SYSTEM - ISO 13485:2016
This is to certify that:

ASAHI INTECC (THAILAND) CO.,LTD.
158/1 Moo 5, Bangkadi Industrial Park,
Tiwanon Road, Tambol Bangkadi,
Amphur Muang Pathumthani,
Pathumthani
12000
ThailandFacility ID Number: F004421
Holds Certificate No:

MDSAP 718545

The company listed on this certificate has been audited to and found to conform with ISO 13485:2016 including thefollowing country specific requirements:
Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) - Full
Quality Assurance Procedure
Brazil: RDC ANVISA n. 67/2009, RDC ANVISA n. 665/2022 - Good Manufacturing Practices, RDC ANVISA n.
551/2021
Canada: Medical Devices Regulations - Part 1 - SOR 98/282
Japan: MHLW MO No 169 (2004), as amended by MHLW MO No 60 (2021), PMD Act
USA: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 - Subparts A to D

Please see scope page.

For and on behalf of BSI:
Graeme Tunbridge, Senior Vice President Medical Devices
Original Registration Date: 2020-05-04

Effective Date: 2023-03-25

Expiry Date: 2026-03-24

Page: 1 of 3

This certificate remains the property of BSI and shall be returned immediately upon request.
An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory
To be read in conjunction with the scope above or the attached appendix.
Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.

Certificate No:

MDSAP 718545

Registered Scope:
The design and development of Catheters for the area of Peripheral vascular.
The manufacture of Guidewire for the area of cardiovascular, peripheral vascular, neurovascular, andurology.
The manufacture of catheters for the area of cardiovascular, peripheral vascular, and neurovascular.

Original Registration Date: 2020-05-04

Effective Date: 2023-03-25

Expiry Date: 2026-03-24
Page: 2 of 3

This certificate remains the property of BSI and shall be returned immediately upon request.
An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory
To be read in conjunction with the scope above or the attached appendix.
Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.

Certificate No:MDSAP 718545

Location

Registered Activities

ASAHI INTECC (THAILAND) CO.,LTD.
N1 Factory / N2 Factory
142/1 Moo 5, Bangkadi Industrial Park,
Tiwanon Road, Tambol Bangkadi,
Amphur Muang Pathumthani,
Pathumthani
12000
ThailandFacility ID Number: F004421

The design and development of Catheters for the area of
Peripheral vascular.

ASAHI INTECC (THAILAND) CO.,LTD.
158/1 Moo 5, Bangkadi Industrial Park,Tiwanon Road, Tambol Bangkadi,
Amphur Muang Pathumthani,
Pathumthani
12000
ThailandFacility ID Number: F004421

The manufacture of Guidewire for the area of cardiovascular,
peripheral vascular, neurovascular, and urology.

ASAHI INTECC (THAILAND) CO.,LTD.
N3 Factory,
149 Moo 5, Bangkadi Industrial Park,
Tiwanon Road, Tambol Bangkadi,
Amphur Muang Pathumthani,
Pathumthani
12000
ThailandFacility ID Number: F004421

The design and development of Catheters for the area ofPeripheral vascular.

Original Registration Date: 2020-05-04

The manufacture of Guidewire for the area of cardiovascular,
peripheral vascular, neurovascular, and urology.
The manufacture of catheters for the area of cardiovascular,peripheral vascular, and neurovascular.

The manufacture of catheters for the area of cardiovascular,peripheral vascular, and neurovascular.

Effective Date: 2023-03-25

Expiry Date: 2026-03-24
Page: 3 of 3

This certificate remains the property of BSI and shall be returned immediately upon request.
An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory
To be read in conjunction with the scope above or the attached appendix.
Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USAA Member of the BSI Group of Companies.